Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

GLOVE CHECK PATIENT EXAMINATION GLOVE LEAK DETECT.

K-Number: K915636 · 1992-07-13

ApplicantAssociated Ent., Inc.
Decision Date1992-07-13
Product CodeLDQ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GLOVE CHECK PATIENT EXAMINATION GLOVE LEAK DETECT. is the device name listed in this FDA 510(k) record. The listed applicant is Associated Ent., Inc.. It received FDA 510(k) clearance on 1992-07-13 under 510(k) number K915636. The device is classified under product code LDQ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLOVE CHECK PATIENT EXAMINATION GLOVE LEAK DETECT.?

GLOVE CHECK PATIENT EXAMINATION GLOVE LEAK DETECT. is a medical device that received FDA 510(k) clearance on 1992-07-13. The listed applicant is Associated Ent., Inc.. The 510(k) number is K915636.

When did GLOVE CHECK PATIENT EXAMINATION GLOVE LEAK DETECT. receive FDA 510(k) clearance?

GLOVE CHECK PATIENT EXAMINATION GLOVE LEAK DETECT. received FDA 510(k) clearance on 1992-07-13, under 510(k) number K915636.

Who is the listed applicant for GLOVE CHECK PATIENT EXAMINATION GLOVE LEAK DETECT.?

The FDA 510(k) record lists Associated Ent., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLOVE CHECK PATIENT EXAMINATION GLOVE LEAK DETECT.?

The FDA product code for GLOVE CHECK PATIENT EXAMINATION GLOVE LEAK DETECT. is LDQ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Associated Ent., Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K924837DISP MONIT POUCH /GLOVE CK PAT EXAM GLOVE LEAK DETK891835BUD BRAND PATIENT EXAMINATION GLOVES (VINYL)K891836BUD BRAND PATIENT EXAMINATION GLOVES (LATEX)

Related Devices (Code: LDQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K993797EC-7701 FLUID WARMING CABINETEnthermics Medical Systems, Inc.K992258HOT SHOT FLUID WARMER IV FLUIDSInfra-Med Technologies, Inc.K981032PIV SYSTEMMedical Solutions, Inc.K973747CONTROLLED TEMPERATURE CABINET SYSTEMSmithK955661ACU-HALTGlederer & Co., Inc.K955776ACU-LABGlederer & Co., Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑